Intravitreal Bevacizumab for Neovascular Glaucoma

NCT ID: NCT00384631

Last Updated: 2008-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-03-31

Brief Summary

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Several studies have confirmed high levels of vascular endothelial growth factor (VEGF) in eyes with neovascular glaucoma (NVG). The role of VEGF inhibitors in regression of other neovascular disorders such as wet-type age-related macular degeneration and diabetic macular edema has been described. We aim to evaluate the effect of three intravitreal injections of bevacizumab (Avastin) 2.5 mg versus a sham procedure for treatment of NVG. Outcome measures include intraocular pressure and extent of iris neovascularization. Both study arms will receive conventional treatment for NVG.

Detailed Description

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Conditions

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Neovascular Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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2

Group Type SHAM_COMPARATOR

subconjunctival normal saline

Intervention Type OTHER

0.1cc normal saline injection in the subconjunctival space repeated twice at monthly intervals

1

Group Type EXPERIMENTAL

Avastin

Intervention Type DRUG

intravitreal injection of avastin 2.5mg repeated twice at monthly intervals

Interventions

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subconjunctival normal saline

0.1cc normal saline injection in the subconjunctival space repeated twice at monthly intervals

Intervention Type OTHER

Avastin

intravitreal injection of avastin 2.5mg repeated twice at monthly intervals

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of NVG
* Vision less than 20/200
* age 10-80 years

Exclusion Criteria

* Uncontrolled Blood Pressure
* History of thromboembolism
* Congestive Heart Failure
* Renal Failure
* Pregnancy or Lactation
* Active ocular or periocular infection
* No light perception
Minimum Eligible Age

10 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Shahin Yazdani, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Research Center, Shaheed Beheshti Medical University

Locations

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Labbafinejad Medical Center

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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8414

Identifier Type: -

Identifier Source: org_study_id

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